Techniques and methods for storing and transferring registration, atlas, and lead information between medical devices

Kothandaraman , et al. March 28, 2

Patent Grant 9604067

U.S. patent number 9,604,067 [Application Number 13/957,353] was granted by the patent office on 2017-03-28 for techniques and methods for storing and transferring registration, atlas, and lead information between medical devices. This patent grant is currently assigned to Boston Scientific Neuromodulation Corporation. The grantee listed for this patent is BOSTON SCIENTIFIC NEUROMODULATION CORPORATION. Invention is credited to Sridhar Kothandaraman, Michael A. Moffitt.

United States Patent 9,604,067
Kothandaraman ,   et al. March 28, 2017
Techniques and methods for storing and transferring registration, atlas, and lead information between medical devices

Abstract

A neurostimulator system includes a portable component configured for storing patient-specific data, and an external control device configured for obtaining the patient-specific data from the portable component. The portable component is an implantable neurostimulator, a patient's remote controller, and/or an external charger. The patient-specific data is imaging-related data. A method of storing data in a neurostimulation system includes generating patient-specific data, and storing the patient-specific data in at least one of the portable components. A method for programming the implantable neurostimulator includes receiving the patient-specific data from the portable component, simulating a volume of tissue activation for each of one or more candidate stimulation parameters, wherein the simulation is based at least in part on the patient-specific data, selecting at least one of the candidate stimulation parameters, and programming the implantable neurostimulator with the selected stimulation parameters.

Inventors: Kothandaraman; Sridhar (Valencia, CA), Moffitt; Michael A. (Valencia, CA)
Applicant:
Name City State Country Type

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Valencia
CA
US
Assignee: Boston Scientific Neuromodulation Corporation (Valencia, CA)
Family ID: 49029179
Appl. No.: 13/957,353
Filed: August 1, 2013
Prior Publication Data
Document Identifier Publication Date
US 20140039577 A1 Feb 6, 2014
Related U.S. Patent Documents
Application Number Filing Date Patent Number Issue Date
61679717 Aug 4, 2012
Current U.S. Class: 1/1
Current CPC Class: A61N 1/37235 (20130101); A61N 1/0534 (20130101); A61B 2090/364 (20160201); A61N 1/36062 (20170801); A61B 2034/107 (20160201); A61N 1/0529 (20130101); A61B 34/10 (20160201); A61B 34/20 (20160201)
Current International Class: A61N 1/372 (20060101); A61N 1/36 (20060101); A61B 34/20 (20160101); A61B 34/10 (20160101); A61B 90/00 (20160101); A61N 1/05 (20060101)
Field of Search: ;607/45,46,59,60
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Primary Examiner: Koharski; Christopher D
Assistant Examiner: Bays; Pamela M
Attorney, Agent or Firm: Lowe Graham Jones PLLC Black; Bruce E.
Parent Case Text


RELATED APPLICATION DATA

The present application claims the benefit under 35 U.S.C. .sctn.119 to U.S. provisional patent application Ser. No. 61/679,717, filed Aug. 4, 2012. The foregoing application is hereby incorporated by reference into the present application in its entirety.
Claims


What is claimed is:

1. A method of storing data in a neurostimulation system, the method comprising: generating a first image of a patient's brain and a second image of the patient's brain, the first image generated before a plurality of electrodes are implanted within the patient's brain and the second image generated after the plurality of electrodes are implanted within the patient's brain; generating patient-specific imaging-related data indicating a location of the plurality of electrodes within the patient's brain, the patient-specific imaging-related data generated based on both of the first and second images, wherein the patient-specific imaging-related data is at least one of imaging data of the patient's brain or a transformation data set to transform a generic 3D atlas into a patient-specific 3D atlas; and storing the patient-specific imaging-related data in a portable component of the neurostimulation system, wherein the portable component is selected from the group consisting of an implantable neurostimulator coupled to the plurality of electrodes implanted within the patient's brain and an external charger for transcutaneously charging the implantable neurostimulator, wherein the portable component is either a) implanted in the patient, b) configured and arranged to be worn by the patient, or c) configured and arranged to fit in a palm of a hand of the patient.

2. The method of claim 1, wherein generating the patient-specific imaging-related data comprises generating the imaging data of the patient's brain.

3. The method of claim 2, wherein the imaging data comprises at least one of magnetic resonance imaging data, diffusion tensor imaging data, and computed tomography scan data.

4. The method of claim 1, wherein generating the patient-specific imaging-related data comprises generating the transformation data set using a transformation procedure that transforms the generic 3D atlas into the patient-specific 3D atlas.

5. The method of claim 4, wherein the transformation data set comprises lead orientation information.

6. The method of claim 4, wherein the transformation data set comprises a 4.times.4 matrix.

7. The method of claim 4, wherein the transformation procedure comprises identifying at least three anatomical reference points in a given image of the patient's brain, and, based on locations of three corresponding reference points in the generic 3D atlas, transforming the generic 3D atlas into the patient-specific 3D atlas.

8. The method of claim 7, wherein the at least three anatomical reference points are an anterior commissure, a posterior commissure, and a mid-commissural point of the patient's brain.

9. The method of claim 1, wherein generating the patient-specific imaging-related data comprises performing a registration process between a series of magnetic resonance images and a computed tomography scan image, wherein the series of magnetic resonance images is obtained prior to implanting the plurality of electrodes, and the computer tomography scan image is obtained after implanting the plurality of electrodes.

10. The method of claim 1, wherein storing the patient-specific imaging-related data comprises storing the patient-specific imaging-related data in the implanted neurostimulator.

11. The method of claim 1, wherein storing the patient-specific imaging-related data comprises storing the patient-specific imaging-related data in the external charger.

12. A neurostimulator system comprising: a plurality of electrodes implanted within a patient's brain tissue; a portable component configured for storing patient-specific imaging-related data including a location of the plurality of electrodes within the patient's brain tissue, determined by imaging of the patient's brain tissue, as compared to an image of the patient's brain tissue prior to implantation of the plurality of electrodes, wherein the patient-specific imaging-related data is at least one of imaging data of the patient's brain tissue or a transformation data set to transform a generic 3D atlas into a patient-specific 3D atlas, the portable component selected from the group consisting of: an implantable neurostimulator and an external charger for transcutaneously charging the implantable neurostimulator, wherein the portable component is either a) implantable in the patient, b) configured and arranged to be worn by the patient, or c) configured and arranged to fit in a palm of a hand of the patient; and an external control device configured for obtaining the patient-specific imaging-related data from the portable component, generating a patient-specific anatomical atlas from the patient-specific image-related data, and programming, the portable component with at least one stimulation parameter based on the patient-specific anatomical atlas.

13. The system of claim 12, wherein the patient-specific imaging-related data is the imaging data of the patient's brain tissue.

14. The system of claim 13, wherein the imaging data comprises at least one of magnetic resonance imaging data, diffusion tensor imaging data, and computed tomography scan data.

15. The system of claim 12, wherein the patient-specific imaging-related data is the transformation data set, and wherein the external control device is further configured for generating the patient-specific 3D atlas from the transformation data set and a general anatomical atlas.

16. The system of claim 15, wherein the transformation data set comprises lead orientation information.

17. The system of claim 15, wherein the transformation data set comprises a 4.times.4 matrix.

18. The system of claim 15, wherein the external control device is configured for simulating a volume of tissue activation for each of one or more candidate stimulation parameters, wherein the simulation is based at least in part on the patient-specific imaging-related data, and selecting at least one of the one or more candidate stimulation parameters, and programming the implantable neurostimulator with the at least one selected stimulation parameter.

19. A method for programming an implantable neurostimulator coupled to a plurality of electrodes that are implanted within a patient's brain, comprising: imaging the patient's brain to determine an implanted location of the plurality of electrodes within the patient's brain; receiving patient-specific imaging-related data from a portable component selected from the group consisting of: the implantable neurostimulator and an external charger for transcutaneously charging the implantable neurostimulator, wherein the portable component is either a) implantable in the patient, b) configured and arranged to be worn by the patient, or c) configured and arranged to fit in a palm of a hand of the patient, wherein the patient-specific imaging-related data is at least one of imaging data of the patient's brain or a transformation data set to transform a generic 3D atlas into a patient-specific 3D atlas; generating a patient-specific anatomical atlas from the patient-specific image-related data including the location of the plurality of electrodes within the patient's brain, determined by the imaging of the patient's brain, as compared to an image of the patient's brain prior to implantation of the plurality of electrodes; and programming the portable component with at least one stimulation parameter based on the patient-specific anatomical atlas.

20. The method of claim 19, wherein the patient-specific imaging-related data comprises the imaging data of the patient's brain.

21. The method of claim 20, wherein the imaging data comprises at least one of magnetic resonance imaging data, diffusion tensor imaging data, and computed tomography scan data.

22. The method of claim 19, wherein the patient-specific imaging-related data is the transformation data set, and wherein the method further comprises using the transformation data set to transform the generic 3D atlas into the patient-specific 3D atlas.

23. The method of claim 22, wherein the transformation data set comprises lead orientation information.

24. The method of claim 22, wherein the transformation data set comprises a 4.times.4 matrix.

25. The method of claim 19, further comprising: simulating a volume of tissue activation for each of one or more candidate stimulation parameters, wherein the simulation is based at least in part on the patient-specific imaging-related data; selecting at least one of the one or more candidate stimulation parameters; and programming the implantable neurostimulator with the at least one selected stimulation parameter.
Description


FIELD OF THE INVENTION

The present invention relates to tissue stimulation systems, and more particularly, to implantable stimulators and methods for programming the implantable stimulators.

BACKGROUND OF THE INVENTION

Implantable neurostimulation systems have proven therapeutic in a wide variety of diseases and disorders. Pacemakers and Implantable Cardiac Defibrillators (ICDs) have proven highly effective in the treatment of a number of cardiac conditions (e.g., arrhythmias). Spinal Cord Stimulation (SCS) systems have long been accepted as a therapeutic modality for the treatment of chronic pain syndromes, and the application of tissue stimulation has begun to expand to additional applications, such as angina pectoris and incontinence. Further, in recent investigations, Peripheral Nerve Stimulation (PNS) systems have demonstrated efficacy in the treatment of chronic pain syndromes and incontinence, and a number of additional applications are currently under investigation.

More pertinent to the present inventions described herein, Deep Brain Stimulation (DBS) has been applied therapeutically for well over a decade for the treatment of neurological disorders, including Parkinson's Disease, essential tremor, dystonia, and epilepsy, to name but a few. Further details discussing the treatment of diseases using DBS are disclosed in U.S. Pat. Nos. 6,845,267, and 6,950,707, which are expressly incorporated herein by reference.

Each of these implantable neurostimulation systems typically includes one or more electrode carrying stimulation leads, which are implanted at the desired stimulation site, and a neurostimulator implanted remotely from the stimulation site, but coupled either directly to the neurostimulation lead(s) or indirectly to the neurostimulation lead(s) via a lead extension. The neurostimulation system may further comprise a handheld external control device to remotely instruct the neurostimulator to generate electrical stimulation pulses in accordance with selected stimulation parameters. Typically, the stimulation parameters programmed into the neurostimulator can be adjusted by manipulating controls on the external control device to modify the electrical stimulation provided by the neurostimulator system to the patient.

Thus, in accordance with the stimulation parameters programmed by the external control device, electrical pulses can be delivered from the neurostimulator to the stimulation electrode(s) to stimulate or activate a volume of tissue in accordance with a set of stimulation parameters and provide the desired efficacious therapy to the patient. The best stimulation parameter set will typically be one that delivers stimulation energy to the volume of tissue that must be stimulated in order to provide the therapeutic benefit (e.g., treatment of movement disorders), while minimizing the volume of non-target tissue that is stimulated. A typical stimulation parameter set may include the electrodes that are acting as anodes or cathodes, as well as the amplitude, duration, and rate of the stimulation pulses.

Programming a neurostimulator (e.g., a DBS stimulator for treating movement disorders) can be a laborious and time intensive process that can take many programming sessions over several months to complete. In the context of DBS, neurostimulation leads with a complex arrangement of electrodes that not only are distributed axially along the leads, but are also distributed circumferentially around the neurostimulation leads as segmented electrodes, can be used. The large number of electrodes available, combined with the ability to generate a variety of complex stimulation pulses, presents a huge selection of stimulation parameter sets to the clinician or patient.

To facilitate such selection, the clinician generally programs the external control device, and if applicable the neurostimulator, through a computerized programming system. This programming system can be a self-contained hardware/software system, or can be defined predominantly by software running on a standard personal computer (PC). The PC or custom hardware may actively control the characteristics of the electrical stimulation generated by the neurostimulator to allow the optimum stimulation parameters to be determined based on patient feedback and to subsequently program the external control device with the optimum stimulation parameters.

To facilitate determination of the location of the electrodes relative to the target tissue region or regions, and even the non-target tissue region or regions, the computerized programming system may optionally be capable of storing one or more anatomical regions of interest, which may be registered with the neurostimulation leads when implanted with the patient. The anatomical region of interest may be obtained from a generally available atlas, and in the case of DBS, a brain atlas. Although the use of a generalized brain atlas may be quite helpful when optimizing the stimulation parameters that are ultimately programmed into the neurostimulation system, these types of atlases are not patient specific, and thus, cannot account for patient specific physiology.

After the DBS system has been implanted and fitted, post-implant programming sessions are typically required if the treatment provided by the implanted DBS system is no longer effective or otherwise is not therapeutically or operationally optimum due to, e.g., disease progression, motor re-learning, or other changes. As physicians and clinicians become more comfortable with implanting neurostimulation systems and time in the operating room decreases, post-implant programming sessions are becoming a larger portion of the process.

Regardless of the skill of the physician or clinician, neurostimulation programming sessions can be especially lengthy when programming complicated neurostimulation systems, such as DBS systems, where patients usually cannot feel the effects of stimulation, and the effects of the stimulation may be difficult to observe, are typically subjective, or otherwise may take a long time to become apparent. Clinical estimates suggest that 18-36 hours per patient are necessary to program and assess DBS patients with current techniques (see Hunka K., et al., Nursing Time to Program and Assess Deep Brain Stimulators in Movement Disorder Patients, J. Neursci Nurs. 37: 204-10), which is an extremely large time commitment for both the physician/clinician and the patient.

Recent advances in DBS programming systems include the ability to predict and visualize the stimulation field based on the position of the lead in the anatomy and the electrode configuration. The anatomy is scaled to map to the patient's brain via a process called "registration." Registration involves using the pre-op MR images and post-op CT images of a patient, and generating a "transformation" data set that enables the scaling of a generic 3D brain atlas to represent the specific patient's brain. In addition to the transformation data set, additional information such as the lead data (model, electrodes size/shape/position, connections to the stimulator, orientation of the lead in the brain, etc.) are key to predicting the stimulation field.

It can be appreciated from this that the availability of patient-specific data (e.g., a patient-specific 3D atlas, a lead orientation relative to the patient's tissue, imaging data for the patient, and clinical effects for the patient) has a significant impact on the complexity of, and the amount of time required for, programming a neurostimulator. This patient-specific data may be readily available during implantation of the neurostimulator and is stored within the computerized programming system used during neurostimulator implantation in the operating room. However, once implanted, subsequent programming of the neurostimulator may be impacted by the availability of this patient-specific data. Because the patient-specific data is only stored in the computerized programming system used in the operating room, this same computerized programming system must be used during the navigation session or follow-up reprogramming session, or the patient-specific data must be transferred from the operating room computerized programming system to the new computerized programming system. However, in a clinical setting, it is quite common that the same computerized programming system is not available to program the neurostimulator, and there is a high likelihood that the neurostimulator is programmed or reprogrammed using a different computerized programming system (either in the same hospital/clinic or in a different hospital/clinic).

Significantly contributing to the lengthy process of programming a neurostimulation system is the fact that patient-specific data may not be available during a programming session. Thus, there remains a need for an improved neurostimulator system that allows an external control device to program a neurostimulator implanted within a patient without having prior knowledge of patient-specific data.

SUMMARY OF THE INVENTION

In accordance with a first aspect of the present inventions, a method of storing data in a neurostimulation system is provided. The method includes generating patient-specific imaging-related data, and storing the patient-specific imaging-related data in the at least one portable component. The portable component may be an implantable neurostimulator coupled to a plurality of electrodes implanted within the tissue of a patient, a patient's remote controller used for telemetrically controlling the implantable neurostimulator, and/or an external charger for transcutaneously charging the implantable neurostimulator.

In one embodiment, generating the patient-specific imaging-related data may include generating imaging data of the tissue of the patient (e.g., magnetic resonance imaging data, diffusion tensor imaging data, and/or computed tomography scan data).

In another embodiment, generating the patient-specific imaging-related data may include generating a transformation data set using a transformation procedure that transforms a generic 3D atlas into a patient-specific 3D atlas. The transformation data set may include lead orientation information. The transformation procedure may include identifying at least three anatomical reference points in an image of the patient's brain, and, based on locations of three corresponding reference points in the generic 3D atlas, transforming the generic 3D atlas into a patient-specific 3D atlas. The at least three anatomical reference points may include an anterior commissure, a posterior commissure, and a mid-commissural point of the patient's brain. The transformation data set may be a 4.times.4 matrix.

In one embodiment, generating the patient-specific imaging-related data may include performing a registration process between a series of magnetic resonance images and a computed tomography scan image, wherein the series of magnetic resonance images is obtained prior to implanting the plurality of electrodes, and the computer tomography scan image is obtained after implanting the plurality of electrodes.

In accordance with another aspect of the present inventions, a neurostimulator system is provided. The neurostimulator system includes a portable component configured for storing patient-specific imaging-related data, the portable component selected from the group consisting of: an implantable neurostimulator, a patient's remote controller used for telemetrically controlling the implantable neurostimulator, and an external charger for transcutaneously charging the implantable neurostimulator. The neurostimulator system further includes an external control device configured for obtaining the patient-specific imaging-related data from the portable component, generating a patient-specific anatomical atlas from the patient-specific image-related data, and programming the portable component with at least one stimulation parameter based on the patient-specific anatomical atlas.

In one embodiment, the patient-specific imaging-related data may be imaging data for the tissue of the patient (e.g., magnetic resonance imaging data, diffusion tensor imaging data, and/or computed tomography scan data).

In another embodiment, the patient-specific imaging-related data may be a transformation data set, and the external control device may be further configured for generating the patient-specific anatomical atlas from the transformation data set and a general anatomical atlas. The transformation data set may include lead orientation information. The transformation data set may be a 4.times.4 matrix.

The external control device may optionally be configured for simulating a volume of tissue activation for each of one or more candidate stimulation parameters, wherein the simulation is based at least in part on the patient-specific imaging-related data, and selecting at least one of the candidate stimulation parameters, and programming the implantable neurostimulator with the selected stimulation parameters.

In accordance with yet another aspect of the present inventions, a method for programming an implantable neurostimulator coupled to a plurality of electrodes that are implanted within the tissue of a patient is provided. The method includes receiving patient-specific imaging-related data from a portable component selected from the group consisting of: the implantable neurostimulator, a patient's remote controller used for telemetrically controlling the implantable neurostimulator, and an external charger for transcutaneously charging the implantable neurostimulator.

The patient-specific imaging-related data may be a transformation data set, and the method may further include using the transformation data set to transform a general atlas into a patient-specific atlas. The transformation data set may include lead orientation information. The transformation data set may be a 4.times.4 matrix.

The patient-specific imaging-related data may include imaging data for the tissue of the patient. For example, the imaging data may include at least one of magnetic resonance imaging data, diffusion tensor imaging data, and computed tomography scan data.

The method may optionally comprise simulating a volume of tissue activation for each of one or more candidate stimulation parameters, wherein the simulation is based at least in part on the patient-specific imaging-related data. Still further, the method includes selecting at least one of the candidate stimulation parameters, and programming the implantable neurostimulator with the selected stimulation parameters.

Other and further aspects and features of the invention will be evident from reading the following detailed description of the preferred embodiments, which are intended to illustrate, not limit, the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate the design and utility of preferred embodiments of the present inventions, in which similar elements are referred to by common reference numerals. In order to better appreciate how the above-recited and other advantages and objects of the present inventions are obtained, a more particular description of the present inventions briefly described above will be rendered by reference to specific embodiments thereof, which are illustrated in the accompanying drawings. Understanding that these drawings depict only typical embodiments of the inventions and are not therefore to be considered limiting of its scope, the inventions will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

FIG. 1 is a plan view of a Deep Brain Stimulation (DBS) system constructed in accordance with one embodiment of the present inventions;

FIG. 2 is a profile view of an implantable pulse generator (IPG) and a first embodiment of neurostimulation leads used in the DBS system of FIG. 1;

FIG. 3 is a profile view of an implantable pulse generator (IPG) and a second embodiment of neurostimulation leads used in the DBS system of FIG. 1;

FIG. 4 is a cross-sectional view of one of the neurostimulation leads of FIG. 3, taken along the line 4-4;

FIG. 5 is a cross-sectional view of a patient's head showing the implantation of stimulation leads and an IPG of the DBS system of FIG. 1;

FIG. 6 is front view of a remote control (RC) used in the DBS system of FIG. 1;

FIG. 7 is a block diagram of the internal components of the RC of FIG. 6;

FIG. 8 is a block diagram of the internal components of a clinician's programmer (CP) used in the DBS system of FIG. 1;

FIG. 9 is a flow chart of a method for storing data in a neurostimulation system; and

FIG. 10 is a flow chart of a method for programming an implantable neurostimulator.

DETAILED DESCRIPTION OF THE EMBODIMENTS

At the outset, it is noted that the present inventions may be used with an implantable pulse generator (IPG), radio frequency (RF) transmitter, or similar neurostimulator, that may be used as a component of numerous different types of stimulation systems. The description that follows relates to a deep brain stimulation (DBS) system. However, it is to be understood that the while the invention lends itself well to applications in DBS, the invention, in its broadest aspects, may not be so limited. Rather, the invention may be used with any type of implantable electrical circuitry used to stimulate tissue. For example, the present invention may be used as part of a pacemaker, a defibrillator, a cochlear stimulator, a retinal stimulator, a stimulator configured to produce coordinated limb movement, a cortical stimulator, a spinal cord stimulator, peripheral nerve stimulator, microstimulator, or in any other neural stimulator configured to treat urinary incontinence, sleep apnea, shoulder sublaxation, headache, etc.

Turning first to FIG. 1, an exemplary DBS neurostimulation system 10 generally includes at least one implantable stimulation lead 12 (in this case, two), a neurostimulator in the form of an implantable pulse generator (IPG) 14, an external remote controller RC 16, a clinician's programmer (CP) 18, an External Trial Stimulator (ETS) 20, and an external charger 22. The IPG 14, RC 16, and charger 22 may be considered to be portable components (i.e., either capable of being implanted within the patient, worn by the patient, or carried by the patient in palm of his or her hand).

The IPG 14 is physically connected via one or more percutaneous lead extensions 24 to the neurostimulation leads 12, which carry a plurality of electrodes 26 arranged in an array. In the illustrated embodiment, the neurostimulation leads 12 are percutaneous leads, and to this end, the electrodes 26 may be arranged in-line along the neurostimulation leads 12. In alternative embodiments, the electrodes 26 may be arranged in a two-dimensional pattern on a single paddle lead if, e.g., cortical brain stimulation is desired. As will be described in further detail below, the IPG 14 includes pulse generation circuitry that delivers electrical stimulation energy in the form of a pulsed electrical waveform (i.e., a temporal series of electrical pulses) to the electrode array 26 in accordance with a set of stimulation parameters.

The ETS 20 may also be physically connected via the percutaneous lead extensions 28 and external cable 30 to the neurostimulation leads 12. The ETS 20, which has similar pulse generation circuitry as the IPG 14, also delivers electrical stimulation energy in the form of a pulse electrical waveform to the electrode array 26 accordance with a set of stimulation parameters. The major difference between the ETS 20 and the IPG 14 is that the ETS 20 is a non-implantable device that is used on a trial basis after the neurostimulation leads 12 have been implanted and prior to implantation of the IPG 14, to test the responsiveness of the stimulation that is to be provided. Thus, any functions described herein with respect to the IPG 14 can likewise be performed with respect to the ETS 20.

The RC 16 may be used to telemetrically control the ETS 20 via a bi-directional RF communications link 32. Once the IPG 14 and stimulation leads 12 are implanted, the RC 16 may be used to telemetrically control the IPG 14 via a bi-directional RF communications link 34. Such control allows the IPG 14 to be turned on or off and to be programmed with different stimulation parameter sets. The IPG 14 may also be operated to modify the programmed stimulation parameters to actively control the characteristics of the electrical stimulation energy output by the IPG 14. As will be described in further detail below, the CP 18 provides clinician detailed stimulation parameters for programming the IPG 14 and ETS 20 in the operating room and in follow-up sessions.

The CP 18 may perform this function by indirectly communicating with the IPG 14 or ETS 20, through the RC 16, via an IR communications link 36. Alternatively, the CP 18 may directly communicate with the IPG 14 or ETS 20 via an RF communications link (not shown). The clinician detailed stimulation parameters provided by the CP 18 are also used to program the RC 16, so that the stimulation parameters can be subsequently modified by operation of the RC 16 in a stand-alone mode (i.e., without the assistance of the CP 18).

The external charger 22 is a portable device used to transcutaneously charge the IPG 14 via an inductive link 38. For purposes of brevity, the details of the external charger 22 will not be described herein. Details of exemplary embodiments of external chargers are disclosed in U.S. Pat. No. 6,895,280, which has been previously incorporated herein by reference. Once the IPG 14 has been programmed, and its power source has been charged by the external charger 22 or otherwise replenished, the IPG 14 may function as programmed without the RC 16 or CP 18 being present.

Referring to FIG. 2, the IPG 14 comprises an outer case 40 for housing the electronic and other components (described in further detail below), and a connector 42 to which the proximal end of the neurostimulation lead 12 mates in a manner that electrically couples the electrodes 26 to the internal electronics (described in further detail below) within the outer case 40. The outer case 40 is composed of an electrically conductive, biocompatible material, such as titanium, and forms a hermetically sealed compartment wherein the internal electronics are protected from the body tissue and fluids. In some cases, the outer case 40 may serve as an electrode.

Each of the neurostimulation leads 12 comprises an elongated cylindrical lead body 44, and the electrodes 26 take the form of ring electrodes mounted around the lead body 44. One of the neurostimulation leads 12 has eight electrodes 26 (labeled E1-E8), and the other neurostimulation lead 12 has eight electrodes 26 (labeled E9-E16). The actual number and shape of leads and electrodes will, of course, vary according to the intended application.

Further details describing the construction and method of manufacturing percutaneous stimulation leads are disclosed in U.S. patent application Ser. No. 11/689,918, entitled "Lead Assembly and Method of Making Same," and U.S. patent application Ser. No. 11/565,547, entitled "Cylindrical Multi-Contact Electrode Lead for Neural Stimulation and Method of Making Same," the disclosures of which are expressly incorporated herein by reference.

In an alternative embodiment illustrated in FIG. 3, the electrodes 26 take the form of segmented electrodes that are circumferentially and axially disposed about the lead body 44. By way of non-limiting example, and with further reference to FIG. 4, one neurostimulation lead 12 may carry sixteen electrodes, arranged as four rings of electrodes (the first ring consisting of electrodes E1-E4; the second ring consisting of electrodes E5-E8; the third ring consisting of electrodes E9-E12; and the fourth ring consisting of E13-E16) or four axial columns of electrodes (the first column consisting of electrodes E1, E5, E9, and E13; the second column consisting of electrodes E2, E6, E10, and E14; the third column consisting of electrodes E3, E7, E11, and E15; and the fourth column consisting of electrodes E4, E8, E12, and E16).

Further details describing the construction and method of manufacturing segmented stimulation leads are disclosed in U.S. patent application Ser. No. 13/212,063, entitled "User Interface for Segmented Neurostimulation Leads," which is expressly incorporated herein by reference.

The IPG 14 further comprises a microcontroller 46 that carries out a program function in accordance with a suitable program stored in memory (not shown). Thus, the microcontroller 46 generates the necessary control and status signals, which allow the microcontroller 46 to control the operation of the IPG 14 in accordance with a selected operating program and stimulation parameters stored within memory 48. Such stimulation parameters may comprise electrode combinations, which define the electrodes that are activated as anodes (positive), cathodes (negative), and turned off (zero), percentage of stimulation energy assigned to each electrode (fractionalized electrode configurations), and electrical pulse parameters, which define the pulse amplitude (measured in milliamps or volts depending on whether the IPG 14 supplies constant current or constant voltage to the electrode array 26), pulse duration (measured in microseconds), pulse rate (measured in pulses per second), and burst rate (measured as the stimulation on duration X and stimulation off duration Y). The IPG 14 may be capable of delivering the stimulation energy to the array 22 over multiple channels or over only a single channel. As will be described in further detail below, the memory 48 may also store patient-specific imaging-related data, as well as lead orientation data and clinical effects data, as discussed in U.S. patent application Ser. No. 13/292,989, entitled "System and Method for Storing Application Specific and Lead Configuration Information in Neurostimulation Device," and U.S. patent application Ser. No. 13/481,524, entitled "Collection of Clinical Data for Graphical Representation and Analysis," which are expressly incorporated herein by reference.

The IPG 14 further comprises telemetry circuitry 50 (including antenna) configured for receiving programming data (e.g., the operating program and/or stimulation parameters) from the RC 16 in an appropriate modulated carrier signal, and demodulating the carrier signal to recover the programming data, which programming data is then stored within the memory. The telemetry circuitry 50 also provides status data to the RC 16.

The IPG 14 further comprises a rechargeable power source 52 for providing the operating power to the IPG 14. The rechargeable power source 52 may, e.g., comprise a lithium-ion or lithium-ion polymer battery. The rechargeable power source 52 is recharged using rectified AC power (or DC power converted from AC power through other means, e.g., efficient AC-to-DC converter circuits, also known as "inverter circuits") received by an AC receiving coil (not shown). To recharge the power source 52, the external charger 22 (shown in FIG. 1), which generates the AC magnetic field, is placed against, or otherwise adjacent, to the patient's skin over the implanted IPG 14. The AC magnetic field emitted by the external charger 22 induces AC currents in the AC receiving coil. Charging circuitry (not shown) rectifies the AC current to produce DC current, which is used to charge the power source 52.

It should be noted that rather than having a fully contained IPG, the system 10 may alternatively utilize an implantable receiver-modulator (not shown) connected to the catheter(s) 12. In this case, the power source, e.g., a battery, for powering the implanted receiver, as well as control circuitry to command the receiver-stimulator, will be contained in an external controller inductively coupled to the receiver-stimulator via an electromagnetic link. Data/power signals are transcutaneously coupled from a cable-connected transmission coil placed over the implanted receiver-modulator. The implanted receiver-modulator receives the signal and delivers the therapy in accordance with the control signals.

As shown in FIG. 5, two percutaneous neurostimulation leads 12 are introduced through a burr hole 62 (or alternatively, two respective burr holes) formed in the cranium 64 of a patient 60, and introduced into the parenchyma of the brain 66 of the patient 60 in a conventional manner, such that the electrodes 26 are adjacent a target tissue region, the stimulation of which will treat the dysfunction (e.g., the ventrolateral thalamus, internal segment of globus pallidus, substantia nigra pars reticulate, subthalamic nucleus, or external segment of globus pallidus). Thus, stimulation energy can be conveyed from the electrodes 26 to the target tissue region to change the status of the dysfunction. Due to the lack of space near the location where the stimulation leads 12 exit the burr hole 62, the IPG 14 is generally implanted in a surgically-made pocket either in the chest, or in the abdomen. The IPG 14 may, of course, also be implanted in other locations of the patient's body. The lead extension(s) 24 facilitates locating the IPG 14 away from the exit point of the stimulation leads 12.

Referring now to FIG. 6, one exemplary embodiment of an RC 16 will now be described. As previously discussed, the RC 16 is capable of communicating with the IPG 14, CP 18, or ETS 20. The RC 16 comprises a casing 100, which houses internal componentry (including a printed circuit board (PCB)), and a lighted display screen 102 and button pad 104 carried by the exterior of the casing 100. In the illustrated embodiment, the display screen 102 is a lighted flat panel display screen, and the button pad 104 comprises a membrane switch with metal domes positioned over a flex circuit, and a keypad connector connected directly to a PCB. In an optional embodiment, the display screen 102 has touchscreen capabilities. The button pad 104 includes a multitude of buttons 106, 108, 110, and 112, which allow the IPG 14 to be turned ON and OFF, provide for the adjustment or setting of stimulation parameters within the IPG 14, and provide for selection between screens.

In the illustrated embodiment, the button 106 serves as an ON/OFF button that can be actuated to turn the IPG 14 ON and OFF. The button 108 serves as a select button that allows the RC 16 to switch between screen displays and/or parameters. The buttons 110 and 112 serve as up/down buttons that can actuated to increment or decrement any of stimulation parameters of the pulse generated by the IPG 14, including pulse amplitude, pulse width, and pulse rate. For example, the selection button 108 can be actuated to place the RC 16 in an "Pulse Amplitude Adjustment Mode," during which the pulse amplitude can be adjusted via the up/down buttons 110, 112, a "Pulse Width Adjustment Mode," during which the pulse width can be adjusted via the up/down buttons 110, 112, and a "Pulse Rate Adjustment Mode," during which the pulse rate can be adjusted via the up/down buttons 110, 112. Alternatively, dedicated up/down buttons can be provided for each stimulation parameter. Rather than using up/down buttons, any other type of actuator, such as a dial, slider bar, or keypad, can be used to increment or decrement the stimulation parameters. Further details of the functionality and internal componentry of the RC 16 are disclosed in U.S. Pat. No. 6,895,280, which has previously been incorporated herein by reference.

Referring to FIG. 7, the internal components of an exemplary RC 16 will now be described. The RC 16 generally includes a controller/processor 114 (e.g., a microcontroller), memory 116 that stores an operating program for execution by the controller/processor 114, as well as stimulation parameter sets. The memory 116 may also store patient-specific imaging-related data, as well as lead orientation data and clinical effects data, as discussed in U.S. patent application Ser. No. 13/292,989, entitled "System and Method for Storing Application Specific and Lead Configuration Information in Neurostimulation Device," and U.S. patent application Ser. No. 13/481,524, entitled "Collection of Clinical Data for Graphical Representation and Analysis," which have been expressly incorporated herein by reference.

The RC 16 further comprises telemetry circuitry 118 for outputting stimulation parameters to the IPG 14 and receiving status information from the IPG 14, and input/output circuitry 120 for receiving stimulation control signals from the button pad 104 and transmitting status information to the display screen 102 (shown in FIG. 6). As well as controlling other functions of the RC 16, which will not be described herein for purposes of brevity, the controller/processor 114 generates new stimulation parameter sets in response to the user operation of the button pad 104. These new stimulation parameter sets would then be transmitted to the IPG 14 via the telemetry circuitry 118. Further details of the functionality and internal componentry of the RC 16 are disclosed in U.S. Pat. No. 6,895,280, which has previously been incorporated herein by reference. Notably, while the controller/processor 114 is shown in FIG. 7 as a single device, the processing functions and controlling functions can be performed by a separate controller and processor.

As briefly discussed above, the CP 18 greatly simplifies the programming of multiple electrode combinations, allowing the physician or clinician to readily determine the desired stimulation parameters to be programmed into the IPG 14, as well as the RC 16. Thus, modification of the stimulation parameters in the programmable memory of the IPG 14 after implantation is performed by a clinician using the CP 18, which can directly communicate with the IPG 14 or indirectly communicate with the IPG 14 via the RC 16. That is, the CP 18 can be used by the physician or clinician to modify operating parameters of the electrode array 26 in the brain.

The overall appearance of the CP 18 is that of a laptop personal computer (PC), and in fact, may be implanted using a PC that has been appropriately configured to include a directional-programming device and programmed to perform the functions described herein. Alternatively, the CP 18 may take the form of a mini-computer, personal digital assistant (PDA), smartphone, etc., or even a remote control (RC) with expanded functionality. Thus, the programming methodologies can be performed by executing software instructions contained within the CP 18. Alternatively, such programming methodologies can be performed using firmware or hardware. In any event, the CP 18 may actively control the characteristics of the electrical stimulation generated by the IPG 14 to allow the optimum stimulation parameters to be determined based on patient response and feedback and for subsequently programming the IPG 14 with the optimum stimulation parameters.

Referring to FIG. 8, to allow the user to perform these functions, the CP 18 includes a standard user input device 122 (e.g., a keyboard, mouse, joystick, etc.) to allow a clinician to input information and control the process and a display monitor 126 housed in a case. In the illustrated embodiment, the monitor 126 is a conventional screen. Alternatively, instead of being conventional, the monitor 126 may be a digitizer screen, such as touchscreen (not shown), and may be used in conjunction with an active or passive digitizer stylus/finger touch. The CP 18 generally includes a controller/processor 130 (e.g., a central processor unit (CPU)) and memory 132 that stores a stimulation programming package 134, which can be executed by the controller/processor 130 to allow the user to program the IPG 14, and RC 16. The CP 18 further includes telemetry circuitry 136 for downloading stimulation parameters to the IPG 14 and RC 16 and for uploading stimulation parameters (as well as patient-specific imaging related data) already stored in the IPG 14 and RC 16. Notably, while the controller/processor 130 is shown in FIG. 8 as a single device, the processing functions and controlling functions can be performed by a separate controller and processor. Thus, it can be appreciated that the controlling functions described below as being performed by the CP 18 can be performed by a controller, and the processing functions described below as being performed by the CP 18 can be performed by a processor.

Execution of the programming package 134 by the controller/processor 130 provides a multitude of display screens (not shown) that can be navigated through via use of the user input device 122. These display screens allow the clinician to, among other functions, to select or enter patient profile information (e.g., name, birth date, patient identification, physician, diagnosis, and address), enter procedure information (e.g., programming/follow-up, implant trial system, implant IPG, implant IPG and lead(s), replace IPG, replace IPG and leads, replace or revise leads, explant, etc.), generate a therapeutic map (e.g., body regions targeted for therapy, body regions for minimization of side-effects, along with metrics (e.g., Unified Parkinson's Disease Rating Scale (UPDRS)) of success for said targets) of the patient, define the configuration and orientation of the leads, initiate and control the electrical stimulation energy output by the leads 12, and select and program the IPG 14 with stimulation parameters in both a surgical setting and a clinical setting. Further details discussing the above-described CP functions are disclosed in U.S. patent application Ser. No. 12/501,282, entitled "System and Method for Converting Tissue Stimulation Programs in a Format Usable by an Electrical Current Steering Navigator," and U.S. patent application Ser. No. 12/614,942, entitled "System and Method for Determining Appropriate Steering Tables for Distributing Stimulation Energy Among Multiple Neurostimulation Electrodes," which are expressly incorporated herein by reference.

The user interface includes a series of programming screens with various control elements that can be actuated to perform functions corresponding to the control elements. In the illustrated embodiment, control elements are implemented as a graphical icon that can be clicked with a mouse in the case of a conventional display device. Alternatively, the display device may have a digitizer screen (e.g., a touchscreen) that can be touched or otherwise activated with an active or passive digitizer stylus. More alternatively, the control elements described herein may be implemented as a joy stick, touchpad, button pad, group of keyboard arrow keys, mouse, roller ball tracking device, horizontal or vertical rocker-type arm switches, etc., that can be pressed or otherwise moved to actuate the control elements. Alternatively, other forms of entering information can be used, such as textual input (e.g., text boxes) or microphones.

Significantly, during implantation and initial set up of the system 10, patient-specific imaging-related data is generated, and optionally the lead orientation and clinical effects data briefly discussed above. Such patient-specific imaging-related data may include imaging data for the tissue of the patient, such as magnetic resonance imaging (MRI) data, diffusion tensor imaging (DTI) data, and computed tomography (CT) scan data. Additionally or alternatively, the patient-specific imaging-related data may include a transformation data set that is generated using a transformation procedure that transforms a generic 3D atlas into a patient-specific 3D atlas. The transformation data set may also include lead orientation information. The transformation data set may be a 4.times.4 matrix.

Generating the patient-specific imaging-related data may be a complicated procedure, and may require expertise that is only available during initial device implantation and set up. Thus, it is advantageous for the patient-specific imaging-related data to be stored on one or more of the portable components of the system, so that the patient-specific imaging-related data may be easily accessed by external control devices (e.g., a CP 18) during subsequent programming sessions.

As such, the CP 18 is configured for obtaining the patient-specific imaging-related data from the portable component. As discussed in greater detail below, the CP 18 is also configured for generating a patient-specific anatomical atlas from the patient-specific imaging-related data, and for programming the portable component with at least one stimulation parameter based on the patient-specific anatomical atlas.

Having described the arrangement and function of the components within the neurostimulation system 10, one method 200 of storing data patient-specific imaging-related data in one of the portable components of the system 10 will now be described with reference to FIG. 9. This method 200 may be performed by the initial external control device that is used during the implantation and initial follow-up visits.

First, the patient-specific imaging-related data is generated during implantation or initial set up of the system 10 (step 202). For example, imaging data of the tissue of the patient, such as MRI data, DTI data, and/or CT scan data, may be generated.

In another example, a transformation data set may be generated. In a method for generating the transformation data set, MR images of the patient's brain are obtained prior to implanting the IPG 14 and electrodes 26. After the IPG 14 and electrodes 26 are implanted, a CT scan of the patient's brain is obtained in order to show the location of the leads 12 relative to the patient's brain tissue. The CT scan does not show the brain structures as clearly as the MR images. Thus, through a process called "registration," the CT scan information is mapped onto the MR images. This registration process results in a registered MR image that depicts the brain structures as well as the location of the leads 12 within the brain tissue.

After registration, anatomical reference points within the registered MR image are identified. Such anatomical reference points may include the anterior commissure, the posterior commissure, and the mid-sagittal plane. Anatomical reference points may also include coordinates related to the lead position, such as the lead shaft location and/or the lead tip location. Corresponding coordinates are also identified in a generic brain atlas. For example, the anterior commissure, the posterior commissure, and the mid-sagittal plane are identified in the generic brain atlas. Using the points identified in the MR images of the patient's brain and the points identified in the generic brain atlas, a process called "transformation" is performed in order to transform the generic brain atlas into a patient-specific brain atlas. The output of the transformation is a transformation data set. The registration and transformation procedures may be performed by the initial external control device. Further, the registration and transformation procedures may require user expertise beyond that which is required during subsequent follow-up programming sessions.

The size of the transformation data set is dependent upon the complexity of the transformation procedure. For example, if a tri-linear transformation procedure is performed based on the three anatomical points mentioned above, the resulting transformation data set will be a 4.times.4 matrix. If the transformation procedure is based on several points, the resulting transformation data set will be much larger. For example, the transformation data set may be an 8.times.8.times.8 matrix.

After the patient-specific imaging-related data (e.g., imaging data of the tissue of the patient or transformation data set) is generated (step 202), it is stored on one or more of the portable components of the system 10 (step 204), e.g., by transmitting the patient-specific imaging-related data from the external control device to one or more of the portable components. For example, the patient-specific imaging-related data may transmitted to and stored in the memory 48 of the IPG 14 via the telemetry circuitry 50 (shown in FIGS. 2 and 3), in the memory 116 of the RC 16 via the telemetry circuitry 118 (shown in FIG. 7), and/or the memory (not shown) of the external charger 22. Presumably, these steps are performed during an OR mapping session, or initial follow-up session, so that subsequent CPs are capable of interrogating the one or more portable components for the patient-specific imaging-related data.

One of the advantages of storing the patient-specific imaging-related data in the portable component of the system 10 is that the patient-specific imaging-related data will be readily available during follow-up programming sessions, since the portable component or components will presumably be implanted within, worn by, or otherwise carried by the patient. A method 220 of programming the IPG 14 will now be described with reference to FIG. 10. The programming method 220 may be performed by an external control device (e.g., the CP 18) that is different from the initial external control device.

First, the patient-specific imaging-related data, and optionally the lead orientation and clinical effects data, is acquired from the portable component (e.g., from the memory 48 of the IPG 14 (shown in FIGS. 2 and 3), memory 116 of the RC 16 (shown in FIG. 7), and/or the memory (not shown) of the external charger 22 (step 222). Next, a simulation is performed in which a volume of tissue activation is simulated for each of one or more candidate stimulation parameters (step 224). The simulation is based at least in part on the patient-specific imaging-related data and the optional lead orientation and clinical effects data. For example, if the patient-specific imaging-related data is imaging data for the tissue of the patient (e.g., MRI data, DTI data, and/or CT scan data), the external controller may use the imaging data for the tissue of the patient to perform a transformation procedure, as described above. The patient-specific atlas generated from the transformation procedure is used to approximate a volume of the patient's tissue that may be activated for a plurality of different candidate stimulation parameters.

If the patient-specific imaging-related data is the transformation data set, a patient-specific atlas may be generated by simply applying the transformation data set to a generic atlas. The CP 18 comprises a processor configured to simulate a volume of tissue activation. The CP 18 further comprises a display device configured to display the simulated volume of tissue activation relative to the patient-specific atlas. For example, the volume of tissue activation may be superimposed over the patient-specific atlas. Further details describing the simulation methods are disclosed in U.S. Patent Application Publication No. 2012/0165898, entitled "Neurostimulation System For Selectively Estimating Volume Of Activation And Providing Therapy," the disclosure of which is expressly incorporated herein by reference.

After the simulation is performed, at least one of the tested candidate stimulation parameters is selected (step 226). The selected candidate stimulation parameter set(s) can then be programmed into the IPG 14 and/or RC 16 by transmitting and storing the candidate stimulation parameter set(s) in the memory 46 in the IPG 14 and/or the memory 116 of the RC 16 (step 228).

Although particular embodiments of the present inventions have been shown and described, it will be understood that it is not intended to limit the present inventions to the preferred embodiments, and it will be obvious to those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the present inventions. Thus, the present inventions are intended to cover alternatives, modifications, and equivalents, which may be included within the spirit and scope of the present inventions as defined by the claims.

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References

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